Description
Withings is hiring a Regulatory Affairs and Quality Specialist to support the development and improvement of software-heavy health devices. The role serves as the regulatory and quality reference for projects, helps prepare design and manufacturing dossiers, manages risk and quality-management-system processes, supports CE, MDR, IVDR, and US regulatory submissions, maintains medical-device records, and coordinates with notified bodies and authorities. The position requires a Bac+5 degree in engineering or biomedical fields, prior technical or regulatory experience in medical devices including medical software, knowledge of applicable medical-device standards, and excellent English skills.
